• For the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
• For the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

• Patient has a diagnosis of metastatic colorectal cancer

AND

• Failure or clinically significant adverse effects to fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy (e.g., FOLFOX, FOLFIRI) and an anti-VEGF therapy (e.g., Avastin^R, Zaltrap^R)

AND

• If tumor expresses the KRAS wild type gene, failure or clinically significant adverse effects to an anti-EGFR therapy (e.g., Erbitux^R, Vectibix^R)

OR

• Patient has a diagnosis of locally advanced, unresectable or metastatic gastrointestinal stromal tumor

AND

• Failure or clinically significant adverse effects to Gleevec^R and Sutent^R

• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

• Avastin and Zaltrap are anti-VEGF therapies approved for CRC.
• Erbitux and Vectibix are anti-EGFR therapies approved for CRC.
• Tumors that have a mutation in the codon 12 or codon 13 of the KRAS gene are essentially insensitive to EGFR inhibitors such as Erbitux or Vectibix. Patients with this mutation should not be treated with EGFR inhibitors either alone or in combination with other anticancer agents, as there is virtually no chance of benefit and unnecessary exposure to increased toxicity.
• 5-fluorouracil (5-FU) and Xeloda are examples of fluoropyrimidine chemotherapeutic agents
• A phase II trial of Stivarga for the treatment of renal cell carcinoma has been published.